Jobs · Quality Assurance · Massachusetts

Supplier Quality Senior Specialist

Bristol Myers Squibb EU Policy · Devens, MA · 1 wk ago
Quality Assurance$90k–$108k/yrFull-time

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

About the role

The Supplier Quality Senior Specialist is responsible for work which supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site. This includes vendor qualification and management, material qualification and management, change management and supplier related non-conformance reporting and resolution.

Responsibilities

  • Qualification and management of GMP/GDP vendors, including assessment of vendors, creation and revision of Quality agreements and maintenance of the Approved Vendor List.
  • Lifecycle management of starting materials used for the manufacture of drug substance, including material qualification and requalification, reduced testing, and direct dispense.
  • Assessment of supplier change notifications (SCN) and identification and completion of required actions within the BMS change management system.
  • Assists with internal or external deviations, Supplier Corrective Action Requests (SCAR), and CAPA associated with nonconforming materials or services provided by vendors.
  • Performs review of documents including standard operation procedures, technical documents/reports, agreements, qualifications, and forms.
  • Executes oversight of on-site service vendors throughout the facility in collaboration with the business owners and QA Operations.
  • Exercises sound decision making within generally defined processes to select methods for resolving routine work.
  • Identifies risks to Quality and business continuity and applies appropriate notification to management as appropriate.
  • Collaborates with cross-functional site and network stakeholders with a concise and solution-oriented approach.
  • May represent the team on cross-functional projects and initiatives related to suppliers and materials.
  • May participate in external audits as a support team member under supervision of the lead auditor.

Requirements

  • Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline, or combination of education, experience and training.
  • A minimum of 4 years direct experience in a regulated, biopharmaceutical environment or similar.
  • Practical knowledge of US and EU cGMP regulations and guidance and ISO standards.
  • Familiarity with common electronic systems such as SAP, Veeva, and Syncade.
  • Demonstrated work experience that reflects attention to detail, personal accountability, and a collaborative mindset that delivers results.
  • Excellent written and oral communication skills.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Pay

Devens - MA - US: $89,530 - $108,490 (full-time employee basis). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life Benefits:
    • Paid Time Off (US Exempt Employees): Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
    • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
    • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Schedule

BMS has an occupancy structure that determines where an employee is required to conduct their work. This role is site-by-design, which may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.

Similar jobs

Senior Supplier Quality

Persimmon Technologies CorporationBedford, MA· 3 wk ago
Quality Assurance$120k–$140k/yrapply on apply.appone.com